MID · Class II · 21 CFR 866.5660

FDA Product Code MID: System, Test, Anticardiolipin Immunological

Leading manufacturers include Zeus Scientific, Inc., Inova Diagnostics, Inc. and Corgenix, Inc..

94
Total
94
Cleared
155d
Avg days
1991
Since
94 devices
73–94 of 94
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGG-ACA) TEST
K933786
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Mar 07, 1995
ANTI-CARDIOLIPIN ANTIBODY (IGM-ACA) TEST
K933788
Immco Diagnostics, Inc.
Immunology · 580d
Cleared Oct 13, 1994
APHLELISA KIT
K933588
Louisville Apl Diagnostics, Inc.
Immunology · 444d
Cleared Sep 20, 1994
ELIAS CARDIOLIPIN ANTIBODIES
K940403
Elias U.S.A., Inc.
Immunology · 236d
Cleared Jun 30, 1994
HEMAGEN ACL IGA CALIBRATOR
K941840
Hemagen Diagnostics, Inc.
Immunology · 78d
Cleared Jan 24, 1994
SYNELISA CARDIOLIPIN ANTIBODIES
K935288
Elias U.S.A., Inc.
Immunology · 82d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392
Elias U.S.A., Inc.
Immunology · 149d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393
Elias U.S.A., Inc.
Immunology · 149d
Cleared Jul 16, 1993
HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0
K932373
Hemagen Diagnostics, Inc.
Immunology · 60d
Cleared Jul 06, 1993
ANTI-CARDIOLIPIN ANTIBODY SCREENING TEST SYSTEM
K932225
Immuno Concepts, Inc.
Immunology · 60d
Cleared Nov 30, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K924421
Elias U.S.A., Inc.
Immunology · 90d
Cleared Sep 29, 1992
QUANTA LITE(TM) IGA ACA
K922351
Inova Diagnostics, Inc.
Immunology · 133d
Cleared Sep 28, 1992
QUANTA LITE ACA SCREEN
K923320
Inova Diagnostics, Inc.
Immunology · 83d
Cleared Sep 25, 1992
DIASTAT TOTAL ANTI-CARDIOLIPIN KIT
K923886
Shield Diagnostics, Ltd.
Immunology · 52d
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 03, 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265
Shield Diagnostics, Ltd.
Immunology · 140d
Cleared Jun 04, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K921250
Elias U.S.A., Inc.
Immunology · 80d
Cleared Dec 18, 1991
READS(R) IGA ANTI-CARDIOLIPIN TEST KIT
K914405
Reads Medical Products, Inc.
Immunology · 77d
Cleared Dec 09, 1991
ANTI-CARDIOLIPIN ANTIBODY TEST SYSTEM
K911661
Immuno Concepts, Inc.
Immunology · 241d
Cleared Nov 27, 1991
3M ANTI-CARDIOLIPIN FAST(TM) TEST
K913054
3M Diagnostic Systems, Inc.
Immunology · 141d
Cleared Nov 19, 1991
QUANTA LITE(TM) ACA
K911680
Inova Diagnostics, Inc.
Immunology · 218d